INSIGHT-IBD Pragmatic Study

NCT07686757 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 103899
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice. The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States. The main questions it aims to answer are:

• Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
• Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
• Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization. Participants will:
• Receive either mirikizumab or standard biologic therapy as part of routine clinical care
• Attend follow-up visits at approximately 3, 6, 12, and 18 months
• Have clinical data collected from electronic health records and healthcare utilization sources
• Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
• Undergo routine laboratory tests and clinical assessments as part of standard care

Conditions

Ulcerative Colitis (UC); Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Requiring an Increase in IBD Disease Management

  The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.

  Up to 18 months following initiation of therapy

Secondary Outcomes (17)

• Change in Disease Activity Measured by Crohn's Disease PRO2 Scores

  Baseline, 6 months, 12 months, and 18 months

• Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores

  Baseline, 6 months, 12 months, and 18 months

• Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)

  Up to 18 months (as available from routine clinical care)

• Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.

  Up to 18 months (as available from routine clinical care)

• Treatment Persistence

  Up to 18 months

Study Arms (2)

Mirikizumab Clinical Care Pathway

ACTIVE COMPARATOR

Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.

Drug: Mirikizumab

Standard Biologic Therapy Clinical Care Pathway

ACTIVE COMPARATOR

Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.

Drug: Anti-TNF agents; Drug: anti-integrin antibodies; Drug: IL-12; Drug: IL-23

Interventions

Mirikizumab DRUG

Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.

Mirikizumab Clinical Care Pathway

Anti-TNF agents DRUG

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Standard Biologic Therapy Clinical Care Pathway

anti-integrin antibodies DRUG

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Standard Biologic Therapy Clinical Care Pathway

IL-12 DRUG

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Standard Biologic Therapy Clinical Care Pathway

IL-23 DRUG

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Standard Biologic Therapy Clinical Care Pathway

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years at the time of enrollment
• Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
• Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
• No prior exposure to mirikizumab and no contraindications to mirikizumab
• Ability to provide informed consent
• Willingness to comply with study procedures and follow-up requirements

You may not qualify if:

• Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
• Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
• Participation in an interventional clinical trial within 90 days prior to enrollment
• History of extensive colorectal resection, including:
• Total proctocolectomy (for UC), or
• Surgical removal of two or more intestinal segments (for CD)
• Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study

Sponsors & Collaborators

• Eli Lilly and Company: collaborator
• Specialty Networks Research.: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

mirikizumab; Interleukin-12; Interleukin-23

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Casey Chapman, MD

  GIA

  PRINCIPAL INVESTIGATOR

• Nicholas Lazarou, MPH, MBA

  Cardinal Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorraine O'Donnell

CONTACT

914-388-4907; lorraine.odonnell@cardinalhealth.com

Jessica Manzyuk

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized, parallel-group study in which participating community gastroenterology practices are randomized to either a mirikizumab treatment pathway or a standard biologic therapy pathway. All eligible patients enrolled at a given site receive the treatment assigned to that site. Patients are followed prospectively under routine clinical care without crossover between treatment groups.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share